Cleared Traditional

ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (K942633) - FDA 510(k) Clearance

Class I Dental device.

K942633 · Oral-B Laboratories · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
328d
Days
Class 1
Risk

K942633 is an FDA 510(k) clearance for the ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Oral-B Laboratories (Redwood City, US). The FDA issued a Cleared decision on April 27, 1995 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K942633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date April 27, 1995
Days to Decision 328 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 127d · This submission: 328d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.